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Not Yet Recruiting NCT07888725

Feasibility Pilot of Remote Mindfulness Training Across Multiple Sites (REFORM Pilot)

Conditions: Psychological Stress

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 60
Sponsor: Institute for Human Development and Potential (IHDP), Singapore

Location: Participants will be recruited online and will never come to the lab for assessments. Singapore

Summary

This is an operational feasibility pilot preceding the main REFORM multi-site randomized controlled trial. Approximately 60 adults across three sites will be randomized equally to one of four remotely delivered audio-guided mental training programmes and will complete 12 sessions over approximately one month. The purpose of the pilot is to assess the feasibility and functioning of the study procedures, including the Qualtrics survey and randomization workflow, participant adherence and experience, Camera HRV data collection and transfer, compensation procedures, and blinding materials. Pilot outcomes will be summarized descriptively. The pilot is not designed for confirmatory efficacy testing. Pilot participants will be excluded from all confirmatory analyses of the subsequent main REFORM trial, and pilot data will not be used to calibrate the Bayesian stopping design, nuisance parameters, or Wave 1 recruitment target.

Eligibility Criteria

Inclusion Criteria: * Has reached the legal age of majority in their country of residence. * Self-reports advanced English proficiency, sufficient to understand all spoken and written study instructions without communication barriers. * Reports no regular yoga or meditation practice during the preceding six months, defined as selecting either "Never" or "Rarely (1-3 times in total)". * Has sufficient vision and hearing to read on-screen instructions and listen to the audio recordings. * Owns a smartphone capable of accessing the Qualtrics survey and installing the Camera HRV application. Exclusion Criteria: \- Current diagnosis of schizophrenia, bipolar disorder, or major depressive disorder for which the individual is currently receiving pharmacological or psychological treatment.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07888725). StuddyBuddy aggregates publicly available trial information.